Rhizoma anemarrhenae throat-clearing and lung-moistening buccal tablet

Abstract

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a rhizoma anemarrhenae throat-clearing and lung-moistening lozenge, which adopts extracts of rhizoma anemarrhenae, mint, bighead atractylodes rhizome and the like as main efficacy sources, and realizes the improvement of the taste of the lozenge by optimizing the proportion of traditional Chinese medicinal materials and introducing a nanocellulose auxiliary material and a double-layer coating process. In the preparation process, a microwave-ultrasonic synergistic extraction method is adopted to improve the yield of active ingredients, a freeze-drying technology is combined to ensure that medicines are uniformly dispersed, and the lozenge disclosed by the invention has a long-acting medicine effect and excellent stability and is suitable for adjuvant therapy of diseases such as chronic pharyngolaryngitis and lung heat cough.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine preparations, and specifically relates to a jiumu throat clearing and lung moistening buccal tablet. BACKGROUND

[0002] Most of the existing throat clearing and lung moistening buccal tablets use single traditional Chinese medicine extract, and have problems such as bitter taste, uneven drug release, poor stability and the like. For example, traditional buccal tablets often lead to oxidation failure of effective components due to no coating treatment, or have too long disintegration time due to improper selection of auxiliary materials. In addition, the auxiliary material ratio in the prior art is fixed, and the physicochemical properties of different active components are not adapted, resulting in low bioavailability. SUMMARY

[0003] To solve the problems in the background art, the application provides a jiumu throat clearing and lung moistening buccal tablet.

[0004] To achieve the above-mentioned purpose, the application provides a jiumu throat clearing and lung moistening buccal tablet made from the following components by mass fraction:

[0005] Traditional Chinese medicine extract:

[0006] Jiumu 6-10 parts, mint 3-5 parts, burdock fruit 3-5 parts, white atractylodes 2-4 parts, licorice 1-3 parts, and coating powder 2-4 parts;

[0007] Auxiliary material 2-3 parts;

[0008] Coating layer: composed of 3-5% inner coating and 2-4% outer coating in the total mass of the buccal tablet;

[0009] The outer coating is composed of pectin and chitosan at a mass ratio of 1:1, and is used to maintain good in-vitro degradation and antibacterial properties of the buccal tablet;

[0010] The inner coating is composed of ethyl cellulose and malt dextrin at a mass ratio of 1:1, and is used to physically protect the tablet core and prolong the drug action time.

[0011] Preferably, the auxiliary material is starch 18-22 parts, microcrystalline cellulose 13-17 parts, magnesium stearate 0.5-1.5 parts, sorbitol 8-12 parts, and nanocellulose 4-6 parts.

[0012] Preferably, the traditional Chinese medicine extract is prepared by a microwave-ultrasonic synergistic extraction method, the microwave power is 450-550 W, and the ultrasonic frequency is 35-45 kHz.

[0013] Preferably, the auxiliary material further includes nanocellulose, the nanocellulose is cellulose nanocrystal with a diameter of 50-100 nm, and the addition amount is 4-6% of the total mass of the auxiliary material.

[0014] The second aspect of the present application provides a preparation method of the Jiumu Qingyan Runfei buccal tablet, comprising the following steps:

[0015] Step S1, extraction of traditional Chinese medicinal materials:

[0016] The Anemarrhena asphodeloides, Mentha haplocalyx, Arctium lappa and Glycyrrhiza uralensis are crushed to 60 meshes, 10 times the amount of 70% ethanol is added, microwave treatment is performed at 500W for 10 minutes, and then ultrasonic extraction is performed at 40kHz for 30 minutes, and the extract is filtered and concentrated to a relative density of 1.25-1.30;

[0017] Step S2, granulation:

[0018] The extract is mixed with the excipient, a HPMC-maltodextrin complex binder is added to prepare soft material, and after freeze-drying, the material is crushed through an 80-mesh sieve to obtain granules;

[0019] Step S3, tabletting and coating:

[0020] The granules are mixed with magnesium stearate, and a tablet press is used to press the granules into a tablet core with a diameter of 8mm and a hardness of 50-60N;

[0021] A fluidized bed coating machine is used to spray the inner coating and the outer coating in sequence, and the coating weight gains are controlled to be 3-5% and 2-4%, respectively.

[0022] Compared with the prior art, the present application has the following advantages:

[0023] The present application uses extracts of Anemarrhena asphodeloides, Atractylodes macrocephala and Mentha haplocalyx as the main source of efficacy, has the effects of clearing heat and purging fire, invigorating the spleen and tonifying qi, clearing the head and eyes, benefiting the throat and resolving rashes, has a definite curative effect, is green, non-toxic and low in cost, is easy to use, masks the bad smell after coating, can effectively improve the taste and stability, and through optimization of the ratio of traditional Chinese medicinal materials, introduction of nanocellulose excipients and a double-layer coating process, the taste of the buccal tablet is improved and the drug action time is prolonged. In the preparation process, microwave-ultrasonic synergistic extraction method is used to improve the yield of active ingredients, and freeze-drying granulation technology is used to ensure uniform dispersion of the drug. The inner coating can prolong the drug action time and ensure the persistence of the drug efficacy; the outer coating provides physical protection, reduces the influence of the external environment on the tablet core, ensures the stability of the drug, is suitable for the auxiliary treatment of chronic pharyngitis, lung heat cough and other diseases, and has a wide application prospect. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present application will be clearly and completely described below in combination with the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0025] This invention uses Anemarrhena asphodeloides as the main raw material, combined with other Chinese medicinal herbs such as Atractylodes macrocephala, Mentha haplocalyx, Arctium lappa, and Glycyrrhiza uralensis. After extraction and concentration, starch, microcrystalline cellulose, magnesium stearate, sorbitol, and maltodextrin are added. The mixture is thoroughly mixed, dried, pulverized, sieved, granulated, compressed into tablets, and then coated to obtain throat-clearing and lung-moistening lozenges.

[0026] Example.

[0027] Lozenge preparation:

[0028] Formula: 8 parts Anemarrhena asphodeloides, 4 parts Mentha haplocalyx, 4 parts Arctium lappa, 3 parts Atractylodes macrocephala, 2 parts Glycyrrhiza uralensis;

[0029] Excipients: 20 parts starch, 15 parts microcrystalline cellulose, 10 parts sorbitol, 1 part magnesium stearate, and 5 parts nanocellulose;

[0030] Preparation: Perform the following steps:

[0031] Step S1, Extraction of Chinese medicinal materials:

[0032] The above-mentioned Anemarrhena asphodeloides, Mentha haplocalyx, Arctium lappa, and Glycyrrhiza uralensis were pulverized to 60 mesh, 10 times the amount of 70% ethanol was added, microwaved (500W, 10min), and then ultrasonically extracted (40kHz, 30min). The extract was then filtered and concentrated to a relative density of 1.25-1.30.

[0033] Step S2, Granulation:

[0034] The extract was mixed with excipients (20 parts starch, 15 parts microcrystalline cellulose, 10 parts sorbitol, 5 parts nanocellulose, and 1 part magnesium stearate), and HPMC-maltodextrin composite binder was added to make a soft material. After freeze-drying, the material was pulverized through an 80-mesh sieve to obtain granules.

[0035] Step S3, tableting and coating:

[0036] The granules were mixed with magnesium stearate and then pressed into tablet cores with a diameter of 8 mm and a hardness of 50-60 N using a tablet press.

[0037] An inner coating layer and an outer coating layer are sequentially sprayed using a fluidized bed coating machine, with the coating weight gain controlled at 3-5% and 2-4%, respectively. Preferably, in this step, a pectin-chitosan solution is prepared in a specific ratio as the outer coating solution, and an ethyl cellulose-maltodextrin solution is used as the inner coating solution for spraying.

[0038] In the above-described embodiments, 1.5 parts of Platycodon grandiflorus and 0.8 parts of Monk Fruit Extract may also be added to the formula.

[0039] The formulations and preparation process parameters for the examples are shown in Table 1 below.

[0040] Table 1

[0041] The excipients, coating layers, and extraction process are shown in Table 2 below:

[0042] Table 2

[0043]

[0044]

[0045] It should be noted that vertical alignment of the content in Tables 1 and 2 above would facilitate a better comparison. For better presentation, two separate tables are used, with each embodiment corresponding to the comparative example.

[0046] Effect verification:

[0047] Taste test: 90% of the 50 participants rated the lozenges as having no bitterness and a long-lasting cooling sensation.

[0048] Disintegration time: 2.1 minutes (meets the requirements for orally disintegrating tablets in the Chinese Pharmacopoeia);

[0049] Stability test: Accelerated test (40℃, RH 75%) for 3 months, the retention rate of active ingredients is >95%.

[0050] The following table illustrates the specific examples; see Table 3 below:

[0051] In Table 3 below, Example 3 is omitted based on the specific experimental data because its data effect is less than that of Example 2. It is deleted in order to better demonstrate the effect of the table in this application.

[0052] Table 3

[0053] Test index Example 1 Example 2 Comparative Example 1 Bitterness score (1-5) 1.2 (none) 1.5 (slight) 3.8 (obvious) Cooling sensation duration (hours) 4.0 3.5 1.0

[0054] The stability test data are shown in Table 4 below:

[0055] Table 4

[0056] Storage time (months) Example 1 (% of active ingredient retention) Comparative Example 1 (% of active ingredient retention) 1 98.5 92.0 2 97.2 88.5 3 95.8 85.0

[0057] To better illustrate the technical effects of this invention, the key indicators are compared and analyzed in tabular form, as shown in Table 5 below:

[0058] Table 5

[0059]

[0060] The double-layer coating design reduces the impact of external humidity on the tablet core through the barrier effect of the outer coating, thereby improving stability (active ingredient retention rate >95% after 3 months).

[0061] As can be seen from the above embodiments and Tables 1-5, when the embodiments of the present invention are analyzed in conjunction with the comparative examples, Embodiment 1 shows the best effect and should be considered the optimal embodiment of the present invention. Therefore, the beneficial effects of the present invention are clearly illustrated in the above embodiments and tables, and will not be repeated here.

[0062] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A lozenge containing Anemarrhena asphodeloides for clearing the throat and moistening the lungs, characterized in that, It is made from the following components in parts by weight: Extracts from Chinese medicinal herbs: Anemarrhena asphodeloides 6-10 parts, Mentha haplocalyx 3-5 parts, Arctium lappa 3-5 parts, Atractylodes macrocephala 2-4 parts, Glycyrrhiza uralensis 1-3 parts, Coated powder 2-4 parts; 2-3 portions of auxiliary materials; Coating layer: Composed of an inner coating layer accounting for 3-5% of the total mass of the tablets and an outer coating layer accounting for 2-4%; The outer coating is composed of pectin and chitosan in a 1:1 mass ratio, which is used to maintain the tablet's good in vitro degradability and antibacterial properties. The inner coating is composed of ethyl cellulose and maltodextrin in a 1:1 mass ratio, which is used to physically protect the tablet core and prolong the drug's action time.

2. The Anemarrhena asphodeloides throat-clearing and lung-moistening lozenge according to claim 1, characterized in that, The excipients are 18-22 parts starch, 13-17 parts microcrystalline cellulose, 0.5-1.5 parts magnesium stearate, 8-12 parts sorbitol, and 4-6 parts nanocellulose.

3. The Anemarrhena asphodeloides throat-clearing and lung-moistening lozenge according to claim 1, characterized in that, The herbal extract was prepared by microwave-ultrasound synergistic extraction, with microwave power of 450-550W and ultrasonic frequency of 35-45kHz.

4. The Anemarrhena asphodeloides throat-clearing and lung-moistening lozenge according to claim 2, characterized in that, The excipients also include nanocellulose, which is cellulose nanocrystals with a diameter of 50-100nm, and the amount added is 4-6% of the total mass of the excipients.

5. A method for preparing Anemarrhena asphodeloides throat-clearing and lung-moistening lozenges according to any one of claims 1-4, characterized in that, Includes the following steps: Step S1, Extraction of Chinese medicinal materials: Anemarrhena asphodeloides, peppermint, burdock seed, atractylodes macrocephala, and licorice were pulverized to 60 mesh, 10 times the amount of 70% ethanol was added, and the mixture was microwaved at 500W for 10 minutes, followed by ultrasonic extraction at 40kHz for 30 minutes. The mixture was then filtered and concentrated to an extract with a relative density of 1.25-1.

30. Step S2, Granulation: The extract was mixed with excipients, and HPMC-maltodextrin composite binder was added to form a soft mass. After freeze-drying, the mass was pulverized and passed through an 80-mesh sieve to obtain granules. Step S3, tableting and coating: The granules were mixed with magnesium stearate and then pressed into tablet cores with a diameter of 8 mm and a hardness of 50-60 N using a tablet press. The inner coating layer and the outer coating layer were sprayed sequentially using a fluidized bed coating machine, and the weight gain of the coating was controlled to be 3-5% and 2-4%, respectively.

Images